Distributed remote asset and medication management drug delivery system

ABSTRACT

A system and method for communicating and validating patient information including medication delivery information in a care-giving facility is provided. A medical transaction carrier is used to communicate information regarding medication delivery and other patient information between a control system in communication with the care-giving facility&#39;s other information systems and a patient specific asset such as an infusion pump. All information carried by the medical transaction carrier is validated both at the patient specific asset and at the control system. This validation allows for positive control of all transactions even if a medical transaction carrier is lost. The medical transaction carrier may be a smartcard, a FDA such as a Palm™ Pilot, laptop computer, pager, mobile phone, or other device capable of storing and communicating information. The system may use either wired or wireless connections to communicate information between the components of the system.

BACKGROUND

The present invention relates generally to systems for managing patientcare in a health care facility, and more particularly, to systems andmethods for integrating and managing information with respect to medicalcare, medication delivery, asset identification, and verification ofdrug delivery.

Medication errors, that is, errors that occur in the ordering,dispensing and administration of medications, regardless whether thoseerrors caused injury or not, have become a significant problem in thedelivery of healthcare in the institutional setting. Additionally,adverse drug events (“ADE”), which are a subset of medication errors,defined as injuries involving a drug that require medical intervention,and representing some of the most serious medication errors, areresponsible for a large number of patient injuries and death. Aproportion of these errors are preventable, thus healthcare facilitiescontinually search for ways to reduce the possible occurrence ofmedication errors. Various systems and methods are being developed atpresent to reduce the frequency of occurrence and severity ofpreventable adverse drug events (“PADE”) and other medication errors. Inthe administration of medication, focus is typically directed to thefollowing five “rights” or factors: the right patient, the right drug,the right route, the right amount, and the right time. Systems andmethods seeking to reduce ADE's and PADE's should take these five rightsinto consideration.

Several companies are currently marketing or will be marketing hand-heldpersonal digital assistants (“PDA”) that are designed to provide drugadministration scheduling, drug administration verification, and theelectronic documentation drug administration. These devices arepredominantly used to verify administration of oral, intramuscular(“IM”), subcutaneous, and topical drugs and have limited capability inverifying the administration of IV drugs. One disadvantage of thesedevices is they are currently incapable of monitoring or receiving dataregarding the initial and ongoing infusion parameters of an intravenous(“IV”) infusion device.

It is advantageous to have a care management system that combines allthe various medication order and administration services of a healthcarefacility into an integrated, automated system that checks and documentsthe delivery of therapeutic and other drugs to the patient. Such asystem would prevent administering an inappropriate medication to apatient by checking the medication against a database of known allergicreactions and/or side-effects of the drug against the patient's medicalhistory. The integrated system should also provide doctors, nurses, andother care-givers with updated patient information at the bedside,notify the facility's pharmacy when an additional drug is required, orwhen a scheduled treatment is running behind schedule, and automaticallyupdate the facility's accounting database each time a medication orother care is given.

In many hospitals and clinical laboratories, a bracelet device havingthe patient's identification such as his or her name printed thereon ispermanently affixed to a patient upon admittance to the facility inorder to identify the patient during his or her entire stay. Despitethis safeguard, opportunities arise for patient identification error.For example, when a blood sample is taken from a patient, the bloodsample must be identified by manually transcribing the patient's nameand other information from the patient's identification bracelet. Intransferring the patient's name, a nurse or technician may, instead ofactually reading the patient's bracelet, miscopy the name or may rely onmemory or a different data source.

Moreover, manually transferring other information such as parameters forconfiguring an infusion pump to dispense medication may result in errorsthat reduce the accuracy and/or effectiveness of drug administration andpatient care. This may result in an increased duration of treatment withan attendant increase in cost.

Hospitals and other institutions continuously strive to provide qualitypatient care. Medical errors, such as where the wrong patient receivesthe wrong drug at the wrong time, in the wrong dosage, or even where thewrong surgery is performed, are a significant problem for all healthcarefacilities. Many prescription drugs and injections are identified merelyby slips of paper on which the patient's name and identification numberhave been hand-written by a nurse or technician who is to administer thetreatment. For a variety of reasons, such as the transfer of patients todifferent beds and errors in marking the slips of paper, the possibilityarises that a patient may be given an incorrect treatment. This resultsin increased expense for the patient and hospital that could beprevented using an automated system to verify that the patient isreceiving the correct care. Various solutions to these problems havebeen proposed, such as systems that use bar codes to identify patientsand medications, or systems allowing the beside entry of patient data.While these systems have advanced the art significantly, even morecomprehensive systems could prove to be of greater value.

Delivery, verification, and control of medication in an institutionalsetting have traditionally been areas where errors can occur all toofrequently. In a typical facility, a physician enters an order for amedication for a particular patient. This order may be handled either asa simple prescription slip, or it may be entered into an automatedsystem, such as a physician order entry (“POE”) system. The prescriptionslip or the electronic prescription from the POE system is routed to thepharmacy, where the order is filled, hopefully in a timely manner, sothat the medication can be provided to the patient. Typically,pharmacies check the physician order against possible allergies of thepatient and for possible drug interactions in the case where two or moredrugs are prescribed, and also check for contra-indications. Dependingon the facility, the medication may be identified and gathered withinthe pharmacy and placed into a transport carrier for transport to anurse station. Once at the nurse station, the prescriptions are onceagain checked against the medications that have been identified fordelivery to ensure that no errors have occurred.

Typically, medications are delivered to a nurse station in a drug cartor other carrier that allows a certain degree of security to preventtheft or loss of medication. In one example, the drug cart or carrier isdivided into a series of drawers or containers, each container holdingthe prescribed medication for a single patient. To access themedication, the nurse must enter in the appropriate identification tounlock a drawer or door or container. In other situations, inventoriesof commonly used drugs may be placed in a secure cabinet located in anarea close by a nurse station. This inventory may contain not onlytopical medications but oral, IM-, and IV-delivered medications as well.Nurse identification and a medication order number are typicallyrequired to gain access to the cabinet.

The nurse station receives a listing of drugs to be delivered topatients at intervals throughout the day. A nurse or other care-giver orother qualified person reads the list of medications to be delivered,and gathers those medications from the inventory at the nurse station.Once all of the medications have been gathered for the patients in theunit for which the nurse station is responsible, one or more nurses thentake the medications to the individual patients and administer thedosages.

Common to all of these systems is the nurse or other care-giver whodelivers the medication. The nurse or care-giver is central to theprocess of verifying that the right medication is given to the rightpatient in the correct dosage at the right time at the point of care. Noother person in the facility is situated as well as the nurse or othercare-giver delivering the medication to ensure or verify that theappropriate drug is being given to the appropriate patient.

Such a system works well to verify that patients are receiving theappropriate drug when drugs are delivered orally, but the system may notbe capable of thoroughly verifying that the appropriate medicationregimen is being delivered to a patient in the case where IV drugs arebeing delivered. For example, a nurse or other care-giver may carry anIV bag down to a particular patient area, hang the bag, program aninfusion pump with appropriate treatment parameters and begin infusionof the medication. The applicable hospital control system, such as thepharmacy information system, may not know that the patient has receivedthe medication, and if the information is lost somewhere, thepossibility exists of medicating the patient twice. Thus, there may be abreak in the link of verification that the medication is being properlydelivered to the patient if an event occurs resulting in a deviationfrom the desired treatment parameters.

Hence what has been recognized as a need, and has heretofore beenunavailable, is an integrated, modular system for tracking andcontrolling patient care and for integrating the patient careinformation with other institutional databases to achieve a reliable,efficient, cost-effective delivery of healthcare to patients. Theinvention fulfills this need and others.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the present invention is directed to anew and improved information management system and method capable ofmonitoring, controlling and validating the administration of medicalcare delivery in a health care facility.

Generally, the system of the present invention includes a medicaltransaction carrier (“MTC”) that contains information concerning pastand present medical transactions. The medical transaction carrier isused to transfer information relating to past and present medicaltransactions between a control system that is interfaced with variousother care-giving institutional information systems, such as a pharmacyinformation system, or hospital information system, or physician orderentry system, or a patient specific asset located at a patient'sbedside. The information transferred by the medical transaction carrieris used to validate that the right medication and the parameters of themedication administration record are properly delivered to the rightpatient. As is well known by those skilled in the art, the medicationadministration record (“MAR”) is used by nurses to schedule medicationadministration. It is also used to document the actual administration ofthe medications. The medication order from the physician is recorded onthe MAR, either by the pharmacy or the nurse staff members. As doses areadministered, the nurse initials the corresponding time and records anyadditional required information (e.g. pulse rate, blood sugar). The MARcovets a specific period of time, typically 24 to 72 hours. The MAR isthe legal record of drug administration, and it is kept as a permanentpart of the patient's medical record. The system of the presentinvention includes methods for validating the information transferred bythe medical transaction system to ensure that no information is lost.

The medical transaction carrier in accordance with one aspect of thepresent invention may be a personal data assistant (“PDA”), a laptopcomputer, a smart card, a BLUBTOOTH transceiver, or other device capableof storing information and transporting the information from onelocation in a care-giving facility where medications are prepared fordelivery to a patient's bedside. In another aspect, the medicaltransaction carrier may be primarily stationary and located at thepatient's bedside. At the patient's bedside, the medical transactioncarrier is interfaced to a patient specific asset (“PSA”), such as aninfusion pump or vital signs monitor, and the information stored withinthe medical transaction carrier is communicated to the patient specificasset to provide the asset with specific treatment parameters to be usedin delivering medication to the patient or in otherwise interacting withthe patient.

In another aspect of the present invention, the patient specific assetmay include a capability of monitoring the progress of the delivery ofmedication and storing information relating to the delivery of themedication in a memory. The stored information may then be communicatedto the medical transaction carrier for transport back to the controlsystem, where the information is transferred from the medicaltransaction carrier and validated and/or documented by the controlsystem. Documentation may occur in the pharmacy system for example.

In a further aspect of the present invention, the patient specific assetis configured to validate that information related to past medicaltransactions has been communicated to the control system. The controlsystem may also include a capability of validating informationtransferred from the patient specific asset to the control system toensure that all transaction information stored in the patient specificasset has been transferred to the control system for storage in a database. In more detailed aspects, the PSA retains such past medicaltransaction information until it is notified that the control system hasvalidated the information.

In yet another aspect of the present invention, care-givers, patientsand medications may be identified using bar coded labels, RFidentification, BLUETOOTH tags, or other devices. Such other devices mayinclude active devices such as embedded computers or passive devices,such as magnetic strips.

In still another aspect of the invention, information is communicatedbetween the various components of the system using wireless technology.For example, the various components of the system may communicate usinga wireless network utilizing communication protocols such as BLUETOOTH™(IEEE 802.15) or other protocols such as those described in IEEE 802.11,802.11a, and 802.11b. Communication within the wireless network mayutilize radio frequency electromagnetic radiation, infrared radiation orother means for accomplishing wireless communication between networkelements.

In yet another aspect of the invention, the MTC may Lake the form of anelectronic data stream, or message, formatted to include a uniqueidentifier identifying each individual message and medical transactioninformation as described with reference to a physical MTC. In thisaspect, the PSA may be connected, either by a physical connection, or bywireless connection, to a communication network in communication withvarious care facility information systems, such as a pharmacyinformation system. A processor operably connected to the PSA, which maybe included in the same case as the PSA, for example in the case of aninfusion pump, is configured to validate that an electronic MTC isreceived and validated by the care facility's information system beforeclearing the MTC from a memory operably connected to the processor.

These and other advantages of the invention will become apparent fromthe following more detailed description when taken in conjunction withthe accompanying drawings of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graphical representation of a care management systemincorporating principles of the present invention and illustratingdetails of the hardware elements and communications network, and theinterconnections of the elements shown;

FIG. 2 is functional block diagram illustrating information flow betweena medical transaction carrier and a control system of the presentinvention;

FIG. 3 is a functional block diagram illustrating information flowbetween a medical transaction carrier and a patient specific asset ofthe present invention; and

FIG. 4 is a graphical representation of another embodiment of a caremanagement system of FIG. 1 wherein the control system is incorporatedinto a patient specific asset, which is in wireless communication withvarious care facility information systems.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a system and method for monitoring,controlling and tracking the administration of care in a healthcarefacility. Additionally, the present invention also provides for closingthe loop on drug delivery and validation that the right treatment hasbeen given to the right patient.

Referring now to drawings in which like reference numerals are used torefer to like or corresponding elements among the figures, there isgenerally shown in FIG. 1 an integrated hospital-wide information andcare management system in accordance with aspects of the presentinvention. Various subsystems of an facility's information managementsystem are connected together by way of a communication system 5. Thecommunication system 5 may be, for example, a local area network (LAN),a wide area network (WAN), Inter- or intranet based, or some othertelecommunications network designed to carry signals allowingcommunications between the various information systems in the facility.For example, as shown in FIG. 1, the communication system 5 connects,through various interfaces 10, a hospital information system 20, apharmacy information system 30, a physician order entry system 35, and acontrol system 40.

The control system of the present invention may include various hardwarecomponents, such as a computer, for example, an IBM or IBM-compatiblepersonal computer or server, having sufficient mass storage 45, such aslocal hard drives, CD-ROM, magnetic tape, or other media, andappropriate communication interface capabilities to interconnect withthe communication system 5. Although many configurations are possible,in one embodiment, the control system 40 may include hardware such as adata communication router, modem, or other means for communicating withthe hospital network. The control system 40 also includes softwareprograms for carrying out various aspects of the present invention, aswill be discussed more fully below, and basic operational software, suchas an operating system such as Windows, Windows NT or Windows 2000distributed by Microsoft, Inc., Linux, distributed by Red Hat or anyother suitable operating system. The operational software will alsoinclude various auxiliary programs enabling communications with otherhardware or networks, data input and output and report generation andprinting, among other functions. While control system 40 is shown as aseparate piece of equipment, it will be understood that control system40 and mass storage 45 may also be incorporated into another element,such the pump 120 or other system.

The communication system 5 may comprise, for example, an Ethernet (IEEE802.3), a token ring network, or other suitable network topology,utilizing either wire or optical telecommunication cabling. In analternative embodiment, the communication system 5 may comprise awireless system, utilizing transmitters and receivers positionedthroughout the care-giving facility and/or attached to variouscomputers, clinical devices and other equipment used in the facility. Insuch a wireless system, the signals transmitted and received by thesystem could be radio frequency (RF), infrared (IR), or other meanscapable of carrying information in a wireless manner between deviceshaving appropriate transmitters or receivers. It will be immediatelyunderstood by those skilled in the art that such a system may beidentical to the system set forth in FIG. 1, with the exception that nowires are required to connect the various aspects of the system.

In a typical hospital or other care-giving facility, patient rooms,wards, or areas are typically situated in groups located near a nursestation 50, where the nurses assigned to care for the patients in theparticular area carry out the administrative functions of their duties.Typically, these functions include monitoring the patients' charts,preparation of medication orders, and monitoring and recording any otherinformation deemed necessary to track by the facility. There is alsousually a room located adjacent the nurse station that is dedicated tostorage and/or preparation of medications to be delivered to patients.This room may contain inventories of commonly used oral, intramuscularor intravenous medications. Additionally, the room may also be used toformulate the contents of infusion bags in accordance with prescribedtreatment regimens.

The nurse station 50 will typically include a terminal or computersystem 60 connected either directly or through an interface (not shown)to the communication system 5, allowing users at the nurse station toenter arid retrieve patient data or information from other systems, suchas the hospital information system 20, the pharmacy information system30, the physician order entry system 35, or other systems used in thefacility. It should be understood that nor all users will be providedwith access rights to each system. For example, physicians may be ableto access the physician order entry system 35 from the nurse stationsystem 50 to enter, edit or track medication orders, but a nurse mayonly be able to view such orders. Moreover, while the present inventionis described with reference to the computer system 60 being located at anurse station 50, the computer system 60 may also be a satellite systemthat is located anywhere in the care-giving facility where it isconvenient or efficient to do so. Such a satellite computer system maybe operably connected to the communication system 5 using either a wiredor wireless network connection. A printer 65 may also be connected tothe nurse station computer system 60 for printing reports, and a barcode reader 80 may be provided for reading bar codes on medicationlabels, reports or other items having bar coded labels provided foridentification.

In the present invention, the nurse station computer system 60 includesa capability for providing data exchange between the computer system 60and a medical transaction carrier device (MTC) 110. In one embodiment ofthe present invention, the MTC 110 may be interfaced to the nursestation computer system 60 through a cradle 100 or other docking devicethat provides a connection between the MTC 110 and the computer system60. In this embodiment, use of the cradle 100 allows information to flowinto and out of the MTC 110 to the computer system 60. This informationmay then be processed and stored on the computer system 60, or theinformation may be communicated by the computer system 60 to variousother facility information systems over the communication system 5. Inthis manner, information from the pharmacy information system 30, forexample, may be communicated through the communication system 5, thenurse station computer system 60, and the MTC cradle 100 into the MTC110. Similarly, information contained within the MTC 110 may becommunicated through the MTC cradle 100, the nurse station computersystem 60, and the communication system 5 to any of systems 20, 30, 35,or 40.

The medical transaction carrier 110 generally refers to a device thatcontains medication and/or patient specific information that is portablesuch that it can be carried by a nurse or other care-giver to and from apatient's bedside. The MTC 110 may also have a storage capability andtechnology for interfacing with a computer system or network so thatinformation may be communicated between the MTC 110 and other devices,such as computers, clinical devices and the like. The MTC 110 may, butnot necessarily, include a processor.

It should be understood, however, that the general concept embodied inthe MTC is to provide a way of communicating an order for medical carefrom a care facilities information system, such as a pharmacyinformation system or physician order entry system, to a patientspecific asset, and communicating a message from the patient specificasset back to the information system that the order for medical care hasbeen received by the patient specific asset. In another embodiment, thepatient specific asset may also report that the order for medical carewas actually carried out. The message from the patient specific asset iscommunicated to the relevant information system by means of the MTC andthe information system “validates” the message from the patient specificasset with its copy of the order. As used herein, “validate” means“verify” or “corroborate.” For example, the message from the patientspecific asset may contain the unique order identifier. The informationsystem compares that unique order number with order numbers in itsmemory and then indicates in its memory that a patient specific assethas received and or carried out the order. The order is then considered“validated” by the information system.

The patient specific asset includes a memory for storing the deliveredorder until it receives a signal or message from the information systemthat the message from the patient specific asset has been received bythe information system, that the information system validated the orderthat was the subject of the message from the patient specific asset, andthat the patient specific asset is therefore now authorized to clear theorder from its memory. Thus, while various descriptions of a physicallyembodied MTC are provided as exemplary embodiments, it will beunderstood that an electronic message formatted to include appropriateinformation so that the validation by of the present invention may becarried out by operably connected information systems and patientspecific assets processors is within the intended scope of theinvention. More details of such a system are set forth in more detailbelow.

The MTC 110 typically will have stored within it data or informationconcerning various transactions representing the identity and treatmentregimens for medications to be given to a patient, as well as otherinformation, such as care-giver identity, equipment location, patientvital sign information, or any other information sought to be recorded.The MTC 110 may also store data or information concerning primary orsecondary validation of previous and/or duplicate transactions ofmedical treatment information.

While specific examples of a MTC 110 are set forth herein, it will beunderstood that any device that carries out the basic concept of theinvention, i.e., a device that carries patient specific and/or othermedical or treatment information from a nurse station or other source ofinformation to a patient, wherein the information may be downloaded orotherwise communicated to a patient specific asset, and which may inturn receive information from the patient specific asset, willaccomplish the aims of the present invention. A particularlyadvantageous embodiment includes storing information in the MTC 110until the MTC 110 re-establishes a communication connection with thecontrol system 40, whereby the information stored in the MTC 110 may becommunicated to the control system 40. In this manner, the presentinvention closes the loop ensuring that the right medication has beengiven in the right manner to the right patient.

For example, consistent with the present invention, the MTC 110 may beembodied in a hand-held “personal digital assistant” (“PDA”) such as aPalm™ Pilot or a FDA running the Windows™ operating system, a notebookcomputer or other portable computer system. The MTC may also comprise asmartcard such as those that maintain account information and are issuedby banking facilities, such as the American Express Bluecard. Otherembodiments of the MTC may include a magnetic strip card, a PCMCIA card,RF-ID, or other non-volatile memory storage media. The use of suchdevices is advantageous in that devices having a suitably large memoryto accommodate the type of information required by the present inventionto track medication and validate treatment as well as retrieving otherpatient information, are readily available and relatively inexpensive,thus allowing a MTC to be assigned to each individual patient, oralternatively, to an individual clinical device. Additionally, suchdevices are small, compact and easily transportable.

In another embodiment, the MTC may comprise a pager device or a mobiletelephone. Such devices would be particularly useful in a wirelessenvironment, wherein the devices could be programmed to respond tosignals from suitable transmitter/receivers located throughout thehospital.

Alternatively, the MTC 110 may be embodied in any device that includesan active embedded computer. Such an active embedded computer may beeven smaller than a PDA or notebook computer. For the purposes of thepresent invention, such an active embedded computer includes any deviceincorporating a microprocessor and allows for input and/or output ofinformation, whether via electrical, radio frequency or optical means,wireless or direct contact, and which contains its own power supply. Oneexample of an active embedded computer in accordance with this inventionmay be attached to or embedded in the packing or container of amedication to be delivered to a patient. Such devices may typically bemanufactured no larger than, for example, a postage stamp or businesscard and yet include, using micro circuitry, enough processing power,information storage, data or information input and output, and power tobe suitable for use as a medical transaction carrier,

In yet another embodiment of the present invention, the medicaltransaction carrier may be a bar code label which contains informationabout the patient and the medication that is encoded into the bar code.Alternatively, the MTC may simply be an addressable information storagedevice, similar to memory “sticks” used as storage for digital cameras.

Medical transaction carriers in accordance with the present inventionmay be either stand alone, as where the MTC comprises a PDA, notebookcomputer or a smartcard, or alternatively, the MTC may be attached toanother piece of equipment or device. For example, a medical transactioncarrier using wireless technology could be incorporated into amedication carrying case or cart. Moreover, where the MTC is anelectronic message, there need be no physical device used. Instead, aprocessor may be included in a patient specific asset that is configuredto receive an electronic MTC, act on the information carried thereby,formulate a response message into an electronic MTC and transmit anelectronic MTC to a facility's information system. Such a system wouldbe understood to not be strictly portable, but rather stationary, in thesense that no physical device would be used to transport the medicaltransaction information contained in the MTC from one location toanother. Instead, the electronic MTC may be transported either over aphysical communications network, using, for example, wires or opticalwaveguides, or by way of a wireless network.

In another embodiment, such as where the patient specific asset ismodular and includes an advanced programming module (“APM”), such as inthe ALARIS Medical System, Inc. MEDLEY™ PATIENT CARE MANAGEMENT SYSTEM,the APM may include sufficient programming to perform the function of anMTC. In such case, the APM would be in contact with the relevantinformation system, such as the pharmacy information system, and wouldcommunicate to the information system that the patient specific assetreceived the order. The information system may then validate the orderand communicate to the APM that the order has been validated. The APMmay then delete the order from its memory.

It is not unusual at present to find computers 70 located at patientbedsides in a care-giving facility. Such computers 70 may serve a singlepatient, or may serve more than one patient, depending on the design andarrangement of the patient area. There may also be a variety ofequipment or clinical devices attached to the bedside computer 70.Examples of such devices are a bar code reader 80, a printer (notshown), patient monitoring equipment (not shown) for monitoring patientvital signs or other patient specific assets (“PSA”) assigned to thepatient. Examples of such PSA's include an infusion device such as canform a part of the ALARIS Medical Systems, Inc.'s MEDLEY™ MODULARPATIENT CARE SYSTEM. Attention is directed to U.S. Pat. No. 5,713,856entitled “Modular Patient Care System” to Eggers et al. in which the APMis described as an advanced interface unit 100, and is incorporatedherein by reference. In such system, an infusion device may be mountedto an Advanced Programming Module (“APM”). Other devices, such as avital signs monitor or monitors, are envisioned as being mountable tothe APM also. Other infusion or drug delivery devices and/or patientmonitoring equipment such as cardiac or respiratory monitors may alsocomprise or form a part of the PSA.

The bedside equipment and clinical devices are typically equipped withdata communication technology such as RS 232 serial ports or proprietarycommunication ports that allow information and data to be communicatedto and from the equipment or clinical device. Using this communicationtechnology, the bedside equipment and clinical devices may be connectedto the bedside computer system 70, or, alternatively, they may beconnected, either by wire or wireless system, to communication system 5using wireless technology, such as RF, IR, or other wirelesscommunication protocols.

One disadvantage of connecting the equipment or clinical devicesdirectly into the communication system 5 or bedside computer 5 is thatthe PSA thus becomes immobile and relegated to a single location. Thisdisadvantage is addressed by the present invention in that use of theMTC transport information to and from the clinical device or bedsideequipment frees the device or equipment to be moved from one location toanother without requiring changes to a communication network to identifythe equipment or device, as is required where the equipment or device isidentified as a node on the network.

In one embodiment of the present invention, the PSA 120 may include aMTC cradle 100. The MTC cradle 100 may be hardwired to the PSA 120 usingthe PSA's RS 232 or other communication port. Alternatively, the PSA 120may include an integrated MTC cradle. Using such an integrated MTCcradle is advantageous in that it eliminates the need for another itemof equipment that must be connected to the PSA. Of course, where PSAshaving the required MTC cradle technology integrated therein are notavailable, an external MTC cradle 100 must be used. It will also beunderstood by those skilled in the art that, where an external MTCcradle 100 is necessary, the MTC cradle 100 may communicate with the PSA120 using either wired or wireless technology, as described above.

As described previously, one particularly advantageous embodiment of thepresent invention includes a medical transaction carrier 110 that iscapable of communicating information to and from the PSA 120 and thenetwork or control system using wireless technology. For example, theMTC 110 may be understood to include, but is not limited to,communications utilizing optical or infrared transmission, magnetictransmission, or wireless technology where the wireless technology isunderstood to include methodology such as the BLUETOOTH™ technology(IEEE 802.15), standard methodologies such as wireless Internet, WAP orany other proprietary communication scheme using electromagnetic wavesinstead of wires to connect and communicate between devices. Suchwireless communications may also be performed using other wirelessnetworking alternatives, such as those described in the IEEE 802.11xstandards. Wireless technologies are designed to create wirelessnetworks allowing devices such as PDA's, cell phones and personalcomputers to exchange information at relatively high transmissionspeeds.

Using BLUE TOOTH™ technology, for example, data from a PDA, notebookcomputer, or other device such as a smartcard reader may be sent by aninternal BLUE TOOTH™ radio chip embedded in the MTC 110 to a mobiletelephone transmitter/receiver for transmission to a receiver connectedto a server system. Using the IEEE 802.11x standards for example, datais transmitted directly to a receiver, which may be wired into a networkusing Ethernet or other network topology. The MTC is capable of wirelesscommunication using either BLUE TOOTH™ or other technologies (such asthose described in IEEE 802.11x), and may be used throughout a caregiving facility without the disadvantage of requiring cumbersomehardwired devices.

One particular mode of operation of the present invention will now bedescribed. A patient entering a hospital or other care giving facilityis provided with a wristband, necklace, ankle band or other identifierthat is affixed to the patient in a manner so that the patient can beidentified even if the patient is unconscious or otherwise unresponsive.This wristband or other device may include a bar code representing thename of the patient and other information that the institute hasdetermined is important. Additionally, any other information such asage, allergies, or other vital information may be encoded into the barcode. Alternatively, the patient information device may be an activeembedded computer or passive device attached to a wrist band or othercarrier that is attached to the patient. Such a device would beresponsive to devices located throughout the care-giving facility, suchas readers or wireless transmitter/receivers, to provide the identity ofthe patient along with other information when the device is queried.

After the patient is admitted and situated in a bed within the facility,the patient is typically evaluated by a physician and a course oftreatment is prescribed. The physician prescribes a course of treatmentby preparing an order which may request a series of laboratory tests oradministration of a particular medication to the patient. In some case,the physician prepares the order by filling in a form or writing theorder on a slip of paper to be entered into the hospital system forproviding care. In other cases, the physician may enter the medicationorder directly into a physician order entry system 35 (FIG. 1) or mayinstruct a nurse or other care-giving professional to do so.

If the order is for administration of a particular medication regimen,the order will be transmitted to the facility's pharmacy informationsystem 30. The pharmacy reviews the order, and prepares die medicationaccording to the requirements of the physician. Typically, the pharmacypackages the medication in a container, and a copy of the order, or at aminimum the patients name, the drug name, and the appropriate treatmentparameters are represented on a label that is affixed to the drugcontainer. This information may be represented by a bar code, or it maybe stored in a smart label, such as a label having an embedded computeror passive device.

Once the order has been prepared, the order is sent to the nurse stationfor matching with the appropriate patient. Alternatively, if themedication is for a commonly or routinely prescribed medication, themedication may be included in an inventory of medications that is storedin a secure cabinet adjacent the nurse station. In such a case, thenurse station will receive a list of orders from the pharmacyinformation system 30 that may be drawn from the inventory adjacent thenurse station. The nurse will enter here identifier at the cabinet togain access, in accordance with standard practice. The nurse or otherprofessional assigned the task of gathering medications will then matchthe orders received from the pharmacy information system 60 to themedications stored in the inventory and pull those medications that areto be delivered to specific patients. These procedures are carried outwhether the medication to be delivered is an oral medication, or amedication that is to be delivered intramuscularly or through aninfusion.

When the prescribed time for delivery of the medications arrives, themedications are carried to the patient's area and administered to thepatient by the nurse or other care-giver in the case of drugs to bedelivered via infusion, the care-giver hangs the infusion bag, attachesthe bag to an infusion pump, and sets up the infusion pump to deliverthe medication by programming the pump with values for variousparameters that are used by the pump to control delivery of themedication to the patient. The infusion regimen is then started, and,because delivery of an infusion regimen generally extends over aprolonged period of time, the care-giver leaves the patient andcontinues on to care for other patients.

With the advent of modern infusion pumps that incorporatemicroprocessors and storage capability, it has become possible tomaintain a record of not only the programmed infusion parameters, butalso a log of the treatment as it is given to the patient. Until thepresent invention, however, there has been no way to ensure that theinformation gathered by the infusion pump was communicated to a systemthat could incorporate a record of the infusion into the patient'srecords stored in any of the facility's information systems.

Utilizing the present invention, a nurse or care-giver gathering orpreparing medications to be delivered to patients programs a MTC 110with the information appropriate to the particular medical treatmentregimen that is to be delivered to a patient. Because medicaltransaction carriers are relatively inexpensive, there may be anindividual MTC assigned to each patient or PSA 120. As will be discussedbelow, the MTC 110 provides for not only transporting informationbetween care facility information systems and PSAs 120, but it alsoprovides an instrument for validating the medical transaction to ensurethat all information concerning delivery of a medication is retrievedand transferred to the care facility information systems. The system andmethod of the present invention accomplishes this in a manner thatallows for loss of the MTC, or delay in return of the MTC or the use ofdifferent MTCs having different parts of a medical order without loss ofinformation.

A communication session to transfer medical transaction information fora particular patient into a MTC 110 is initiated by inserting the MTC110 into an appropriate slot or cradle for the MTC 100 which is inoperable communication with the control system 40 via the nurse stationcomputer system 60 and communication system 5. Alternatively, the MTC110 may communicate with the control system 40 using a wireless system.As described above, this wireless system may comprise either infrared orRF frequency signals using appropriate communication protocols such asBLUE TOOTH™ or others (such as those described in IEEE 802.11x).

Once a connection has been established between the MTC 110 and thecontrol system 40, the nurse or other care-giver preparing themedication logs into the control system 40 and the transaction may betagged with the care-giver's unique identification. Alternatively,establishing communication between the MTC 110 and the control system 40may automatically cause the system to query the care-giver foridentification, which may be provided using an input device, such as akeyboard, bar code reader, or other device designed to read thecare-giver's identification device.

The information to be transferred to the MTC 110 typically consists oforders for medication or other procedures that have been entered into anfacility's information systems, such as the pharmacy information system60. As each order, either for medication or other procedure, is enteredinto the facility's information systems, it may be given a uniquetransaction identifier. Thus, these identifiers may be associated withorders in a line-by-line manner such that each medication or procedureto be carried out on or delivered to a patient is uniquely identified bya unique transaction identifier. The medical transaction information,including the unique transaction identifiers in the facility informationsystems may be accessed by the control system 4 through communicationssystem 5.

Once the medical transactions are assembled and available for access bythe control system 40, specific infusion delivery protocols, medicationlimits, time-based medication constraints, and/or other patient'sspecific information comprising the medical transaction information maybe transferred to the MTC 110. The amount of information transferred tothe MTC 110 will be dependent only upon the software running on thecontrol system 40, as well as the memory constraints of the MTC 110.Once the specific information has been downloaded from the controlsystem 40 into the MTC 110, the MTC is ready to accompany the medicationto the patient area for treatment of the patient.

In one embodiment, a single MTC may be assigned to a nurse to cover allthe nurse's patients. Thus, the control system 40 may load all medicalorders for a particular nurse for that day or for that nurse's rounds,on a single MTC assigned to that nurse.

In another embodiment, more than one MTC may be used to transmit anorder or orders for a particular patient or patients. Where multipleMTCs are used, the various elements of the system of the presentinvention are programed to determine whether all of the medicaltransaction information contained on the multiple MTC has been receivedand validated. Where one or more MTCs of a multiple MTC transaction havenot been received or validated, the system of the present invention isconfigured to provide an alert to care givers in the care facility thatcorrective action is needed.

At the patient location, the information from the MTC 110 is transmittedto the PSA 120 using either wired or wireless technology. In oneembodiment, the PSA 120 may be specifically configured to receive theMTC 110 to make the connection for transferral of data from the MTC 110to the PSA. For example, where the MTC is a smart card, the PSA mayinclude a slot or other device configured to receive the MTC 110 and toengage the MTC in such a manner as to allow communication between theMTC 110 and the PSA. Various methods for configuring such acommunication connection are well-known in the art and will not bediscussed herein, but may include, for example, connector pads or aninduction coil capable of interfacing with the smart card to enablecommunication of information between the smart card and the PSA 120.

In an alternative embodiment, where the MTC 110 is a smart card having amagnetic strip, the PSA 120 may include a magnetic strip reader capableof reading the encoded information stored in the magnetic strip of theMTC 110. In yet another embodiment, the MTC may include atransmitter/receiver configured such that when the MTC 110 comes withina predetermined distance of the PSA 120, a communication link betweenthe MTC 110 and the PSA 120 is automatically established. Using a uniqueidentifier associated with the specific PSA 120 to be used to deliverthe medication, the MTC 110 may query the PSA 120 to determine if theunique identifier stored in the memory of the MTC 110 matches that ofthe PSA 120. If the unique identifier stored in the MTC 110 does notmatch the identifier transmitted to it by the PSA 120, an error signalmay he generated alerting the care-giver that the MTC 110 iscommunicating with the wrong PSA 120, and that the patient may receivethe wrong medication.

If the MTC 110 queries the PSA 120 and receives a matching identifier,the MTC 110 begins communicating information into a memory of the PSA120. This information may then be utilized by the PSA 120 to set theparticular treatment parameters that are to be used to delivermedication to the patient.

The MTC 110 may also query the PSA 120 for historical records stored inthe memory of the PSA. In this process, information such as a currentkey log, error log, vital signs log, infusion delivery log, medicationdelivery log, transaction identification, maintenance log and other logsand/or other patient data may be transferred from the PSA 120 to the MTC110.

Additionally, the MTC 110 may remain in communication with the PSA 120for the duration of the treatment, although the communication linkbetween the MTC 110 and the PSA 120 may also be broken by removing theMTC 110 from the PSA 120 or cradle 100. At some time in the future, whenthe nurse or other care-giver is making rounds of the patients anddetermines that the treatment is over, communication between the MTC 110and the PSA 120 may be reestablished. Before the MTC 110 is removed fromthe proximity of the PSA 120 at the end of the treatment, the nurse orother care-giver instructs the PSA 120 to transfer desired information,such as that described above, to the MTC 110. The MTC is then removedfrom the PSA 120 or from the cradle 100 attached to the PSA 120 and iscarried by the nurse or care-giver back to the nurse station computersystem 60 or other satellite computer system capable of reading theinformation stored in the MTC 110.

Once at the nurse station computer system 60, the MTC 110 in insertedinto computer system 60 or MTC cradle 100, depending on theconfiguration of the equipment, to begin the process of communicatingthe patient information gathered from the PSA 120 into the storage ofcontrol system 40. Alternatively, particularly in the case where awireless system is used, MTC 110 may be activated as it approacheswithin a predetermined distance of the nurse station computer system 60or another other device, such as a computer system located at a locationother than at the nurse station 50 (not shown) or a remotely locatedtransmitter/receiver configured to establish communication with a MTC,to establish a communication connection with control system 40 overcommunication system 5.

FIG. 2 is a block diagram of one method utilizing the system of thepresent invention illustrating the use of a medical transaction carrier110 (FIG. 1) that is transported by a nurse or other care-giver to thelocation where the medication is to be delivered in communication with apatient specific asset that is to be used to deliver the medication andto retrieve medical transaction information concerning present and pastmedication delivery from the PSA. While the method is described withreference to programming the MTC 110, it will be understood that suchprogramming also includes simply storing information in the MTC 110, anddoes not require that the MTC be capable of processing or running aprogram as those terms are often used in computer technology.

As described previously, the MTC 110 establishes a connection with thecontrolling server 40 in box 300. The controlling server 40 validatesthat this is a transaction with information from a PSA, and creates anew transaction ID for the particular transaction being undertaken inbox 305. In the event that validation cannot occur, the control server40 issues a signal to alert a nurse or care-giver that there is an errorso that appropriate action to remedy the error may be taken.

Once the connection has been established in the box 300, the MTC 110 maybe queried by the control system 40 to transmit unknown deletedtransaction identifications (IDs) that were not found in the informationstored in the PSA 120. The control server 40 analyzes the unknowndeleted transaction IDs, and determines, in box 320, whether or notthese transactions are pending or may be cleared from memory. If thetransactions associated with the undeleted transaction IDs are notpending, control server 40 determines, in box 330, that no action needsto be taken and that these transactions were cleared during a previouscommunication session. In the case where the determination in box 320indicates that the unknown deleted transaction IDs are pending forclearance, the control server 40 marks the transaction as cleared 334.

Once the unknown deleted transaction IDs have been marked as cleared334, the control system 40 sends a signal to the MTC 110 indicating thatthe control system 40 is now ready to receive current information. Thisstep may also be automated, for example, where the MTC 100 includes aprocessor capable of executing a series of program steps independent ofthe control system 40, such that the MTC 110 queries the control system40 to determine if the control system 40 is ready to receiveinformation. In the event that the query receives a positive response,the MTC 110 may then begin transferring current medical transactioninformation. Where the MTC 110 does not receive a positive response fromthe control system 40, indicating that the control system 40 is not yetready to receive information, then the MTC 40 continues to wait andquery the control system until it receives a positive response.

Once the transfer of information and/or data from the MTC 110 to thecontrol system 40 has been initiated in box 345, information stored inthe MTC 110 representing such information as, for example, but notlimited to, a current key log, an error log, vital signs log, infusiondelivery log, medication delivery log, transaction ID, maintenance andother logs, and any other patient data is communicated to the controlsystem 40, where it may be stored in a database 45 associated with thecontrol system 40 in box 340. In this way, the medical transactioninformation communicated by the MCT 110 to the control system 40 may bepermanently associated with a particular PSA.

Once the information contained within the MTC 110 has been transferredto the control system 40 in step 345, the currently cleared andtransferred medical transaction information stored in the MTC 100 may beerased, as indicated in box 350. Alternatively, the information may bearchived to storage media, such as magnetic tape, hard drives, floppydisks, and the like, as indicated in box 355.

The control system 40 executes software programs in box 350 that analyzethe information recently received from the MTC 110 and communicate newinformation for present medication delivery transactions to the MTC 110.Such software programs may include re-validating the past interactionsrecorded in the MTC 110 against data already stored in the PSA database.Where the validation fails, an error signal may be generated by thecontrol system 40 causing a display or paper report to be printednotifying nurses or other care-giving personnel that an error exists.

Additionally, the software running on the control system 40 may analyzenewly entered medical transaction information, such as the name or typeof drug, dosage and delivery parameters, for example, against standarddelivery protocols stored in the hospital or pharmacy informationsystems 20, 30 as well as determining whether there are any druginteractions or other safety information, such as may be stored indatabase that should be brought to the care-giver's attention and/orstored in the MTC 110. The software provides for generating errorsignals or alerts if errors or safety problems are detected during thisstep.

Once the current transaction data is analyzed, the control system 40communicates the transaction information to the MTC 110. Thisinformation, as indicated in box 360, may include current medicaltransaction information and a unique transaction identification. Thisinformation is stored in the memory of the MTC 110 in box 365.

As indicated by box 370, the software running on the control system 40may, if desired, generate various reports such as outcome reports,medical administration records or any other report requested bycare-giving personnel or administrators. Any errors identified duringthe generation of these reports would result in an error signal that mayeither be displayed on a screen or printed in a printed report.

Additionally, as illustrated in box 375, the control system 40 mayexport all of the information transferred from the MTC 110 to thepharmacy information system 30 or hospital information system 20 forfurther processing or storage. Alternatively, the control system 40 maybe programmed to export a selected portion of that data to thosesystems. Again, software running on the control system 40 may beexecuted to compare information stored on the various informationsystems 20, 30 and 35 with information gathered by the control system 40and validate that the information is correct, with any failures invalidation indicated by an error signal generated by the control system40 to alert care-givers that a condition exists that may need attentionand correction.

Once the previous steps have been undertaken to transfer informationfrom a MTC to the control system for past transactions and transferinformation concerning present medical transactions to the MTC have beencompleted, the process terminates at box 380. After terminating theprocess for a particular MTC 110, the process is repeated for each MTC110 to be used to deliver medication in the care giving facility.

Referring now to FIG. 3, a block diagram depicting one embodiment of aprocess illustrating various interactions between a MTC 110 and a PSA120 located at a patient's bedside to communicate information betweenthe MTC 110 and the PSA 120 is illustrated. The MTC 110 establishes aconnection in box 400 with the PSA 120. If a connection cannot beestablished, an error signal is generated to alert the care-giver thatcorrective action must be taken before transfer of information betweenthe MTC 110 and the PSA 120 may occur.

Once the connection has been satisfactorily established in box 400, thePSA 120 takes control of the process and creates a unique transactionID, logs the care-giver's ID, and validates the patient and the PSAassignment in box 105. If any of the information is incorrect, the PSA120 generates an error signal which may cause a message or code to bedisplayed by the PSA 120 or on a display associated with MTC cradle 100.

When the processes depicted in box 405 have been completed, the PSA 120may signal the MTC 110 that it is ready to receive additional data fromthe MTC, and the MTC, in box 410, transmits a current log of pasttransactions ID's received from the PSA that are now stored in thecontrol system database. Alternatively, the PSA 120 may simply addressthe memory of the MTC 110 and retrieve information from that memorywithout requiting any active participation by the MTC 110. The PSA 120then determines, in box 415, whether or not any of the current log ofpast transaction ID's are flagged as pending for clearance.

If none of the current log of past transaction ID's are pending forclearance, the PSA 120 creates a new log of transactions already in box420 and the process branches to box 460. If the current log of pasttransaction ID's are determined to be pending for clearance, then thosetransactions are marked as cleared and deleted from the pendingtransaction log in box 430, and are transmitted to the MTC 110 wherethey are stored in the memory of MTC 110 in box 425. The deletedtransactions may be stored in the PSA 120 database, as indicated by box440.

Once the deleted transaction identifications have been stored in the MTCmemory, information comprising physician orders, drug regimens andpatient's specific protocols for currently planned or scheduled medicaltreatments are transferred to the PSA 120 from the MTC 110 in box 435,and stored in the database of the PSA 120 in step 440. After the currentphysician orders, drug regimens, and patient specific protocols havebeen stored in the PSA 120 database, a software program may be run inthe PSA to validate delivery protocols, drug interactions, and safetyinformation, such as described earlier with reference to a database toensure safe delivery of the medication to the patent in box 445. If anyerrors or safety issues are detected, an error signal is generated thatmay he displayed by the PSA 120, or on a display associated with the MTCcradle 100.

Where medication identification technology such as a bar code anembedded chip, or other identification method is available, a secondcheck of the medication to be delivered may be accomplished asillustrated by box 450. If an error is detected in box 450, thecare-giver is provided with an error signal indicating that correctiveaction is needed.

Once the validations carried out in boxes 445 and/or 450 are completed,a processor in the PSA 120 loads and executes the patient specificinfusion protocols transferred to it by MTC 110 in box 455. Once again,if any errors are detected during this step, the care-giver is providedwith an error signal indicating that corrective action is needed.

Information stored in the PSA 120 related to patient treatments may becommunicated to the MTC 110 as depicted in box 460. For example, acurrent key log, an error log, a vital sign log, infusion delivery log,medication delivery log, transaction ID, unknown deleted transactionID's, maintenance and other logs, and other patient data are may becommunicated to the MTC 110 in box 460, where they are stored in thememory of the MTC 120 in box 470. Once the information is stored in theMTC 110, the MTC 110 may be removed from the PSA 120 or the MTC cradle100 associated with the PSA 120 and transported to the control system40, as illustrated by box 475. Such transportation may includephysically carrying the MTC 110 to a specified location where the MTC110 may be interfaced to and establish communication with the controlsystem 40 and begin the download cycle described with reference to FIG.2. Alternatively, if the MTC 110 is equipped with appropriate wirelesstechnology, the transport to the control system 40 may become activeeither upon initiating the transmission by providing the MTC 110 withappropriate commands, or it may be automatically induced using awireless system. For example, the MTC 110 may be supplied with atransmitter/receiver capable of automatically connecting to thecommunication system 5 to access the control system 40 using a wirelesscommunication protocol such as BLUETOOTH™ or others (for example IEEE802.11x).

It will be apparent from the above description that the validation stepscarried out in the above process are independent of any one transaction.A transaction is not fully cleared from either the PSA or the controlsystem until both the following occur:

(1) The system that originated a transaction receives validation of atransaction requested as executed; and

(2) The system that receives the transaction request receivesnotification that the originating system has received and validated thetransaction execution.

Because of this redundancy and validation, no transaction is cleareduntil it is certain that a transaction has been validated. Thus, in theevent that a specific MTC 110 is lost, or the information stored thereinis delayed in being communicated to the control system 40, each furtheraction at a patient's bedside will retransmit the missing informationuntil the control system database is properly updated. Utilizing thissystem, all medications received by the patient are logged into thecontrol system database, as well as the actual time the medications werereceived. Moreover, the system ensures that the events log of all IVmedications received and/or vital sign history are logged into diecontrol systems database along with the identification of the nurse whogave the medications to the patient. Thus, full closed loop validationof data occurs. Utilizing this system, it will be apparent that theentire system functions in real-time in the critical direction, i.e.nurse to patient delivery of medication; and the system is nearreal-time in the non-critical direction, that is, from the patient'sbedside back into control system, pharmacy information system and/or thehospital information system for closed loop validation of the medicationdelivery.

While the system of the present invention has be described withreference to the situation where patient medication and/or treatment isordered using an facility's information system, and then delivered, thepresent invention is also applicable where treatment is care ormedication is ordered orally by a physician or other care-giver at thepatient's bedside, and is delivered to the patient before the order isentered into the facility's information system. In general, the oralorder must then be entered into the facility's information systemswithin a predetermined period of time (typically 24 hours) to ensurethat the medication administration record (MAR) is properly updated andaccurately reflects the treatment given to the patient.

In the situation where care or medication is carried out before entryinto the facility's information system, the patient specific asset, suchas an infusion pump, stores in its memory the details of the carerequested or the medication delivered, associating the care ormedication details with a unique identifier generated by the patientspecific asset. The next time the patient specific asset is incommunication with a MTC 110, the patient specific asset transfers thecare or medication details in the form of a medical transactionidentified by the associated unique identifier to the MTC 110, which isthen transported to the control system 40. When the medical transactionis transferred to the control system 40, the control system 40, usingthe unique identifier associated with the transaction by the patientspecific asset, stores the medical transaction in the database 45. Thecontrol system 40 also generates a transaction indicating that theinformation has been received by the control system 40, and transfersthat transaction to a MTC 110 that is to transported to the patientspecific asset to communicate to the patient specific asset that thetransaction has been received by the control system 40.

Once the transaction is stored in the database 45, the transaction maybe matched by software running on the control system 40 of others of thefacility's information systems to the entered oral order. If thetransaction cannot be matched to an order, an alert may be providedindicating that: corrective action, in the form of entering the orderinto the facility's information systems or some other action, must betaken. In this manner, the loop is closed, ensuring that the oral orderhas been recorded and that the order has been carried out.

Alternatively, for example where, the patient specific asset is aninfusion pump, the infusion pump may be programmed to sound an alarmafter it has been infusing for a predetermined period of time, forexample, an hour, and it has not received verification from the controlsystem that a written order has been entered into the facility'sinformation systems. Such an alarm may include stopping the infusionuntil an order is received, or may simply generate a visual and/oraudible reminder that the order must be entered into the facility'sinformation system or that a MTC 110 bearing an appropriate medicalinformation transaction should be provided to the pump so that the pumpmay verify that the oral order has been entered.

In this embodiment, the oral order is entered into the informationsystem, such as pharmacy information system 60, and is transferred to aMTC 110 which is then transported to the infusion pump. There, softwarerunning on the infusion pump compares the information in the transactiontransferred to it by the MTC 110 to the information about the currentinfusion stored in the memory of the pump. If the information matches,the pump communicates to the MTC 100 a transaction indicating that ithas received the order. This transaction communication is thentransferred to the control system 40 to inform the control system 40that the infusion pump has received the order.

Referring now to FIG. 4, an alternative embodiment of the presentinvention will be described that provides for transmission of MTCinformation from a care facility's information systems directly to apatient specific asset located at a patient's bedside. In the caremanagement system 500 of this embodiment, a communication system 505interconnects various care facility information systems, such as ahospital information system 520, a pharmacy information system 530 and aphysician order entry system 535 via suitable interfaces 510. Thecommunication system 505 and the interfaces 510 are similar to thecommunication system 5 and the interfaces 10 described with reference toFIG. 1, and those skilled in the art will understand, without furtherdescription here, that all of the embodiments discussed with referencethereto apply here.

The communication system 505 includes a connection to a wirelesstransmitter/receiver 540 through a suitable interface 545. The wirelesstransmitter/receiver 540 is configured to send messages usingelectromagnetic energy, which may include, for example, infrared energyor radio frequency radiation energy, between the communication system505 and remote equipment and devices, such as a nurse station 550 and apatient specific asset 580, that are capable of receiving andtransmitting messages using electromagnetic energy. For example, thenurse station 550 may be operably connected to a transmitter/receiver575, and the patient specific asset may include a built intransmitter/receiver.

The nurse station 550 will typically include a computer system 560, aprinter 565 and may further include an input/output device 570, such asa bar code reader, in addition to a keyboard of the type typically usedwith a computer. As described above, the nurse system computer system560 may be operably connected to a wireless transmitter/receiver 575, orsuch a transmitter/receiver 575 may be incorporated into the computersystem 560. Alternatively, the nurse station computer system 560 may beconnected to the communication system 505 by means of a physicalinterconnection.

This embodiment of the present invention includes a patient specificasset 580 that includes a wireless transmitter/receiver thatcommunicates with the various care facility information systems throughthe communication system 505 using electromagnetic energy 585Alternatively, the patient specific asset 580 may be connected to aseparate wireless transmitter/receiver or it may be connected with thecommunication system 505 using a physical interconnection.

The patient specific asset 580 also includes a memory for storingmedical transaction information and a processor for analyzing medicaltransaction information transmitted to the patient specific asset 580 bythe transmitter/receiver 540, instructing the device or devicescomprising the patient specific asset 580 to carry out the medical careorder contained within the medical transaction information, transmittinga message to the care facility's information systems that the medicalcare order contained in the medical transaction information has beenreceived, storing the medical transaction information in a memory of thepatient specific asset, and clearing the medical transaction informationfrom the memory of the patient specific asset when the patient specificasset receives a message from an information system that it has receivedthe patient specific asset's transmitted message. Such a processor maybe operably connected to, and configured to communicate with andcontrol, one or more clinical devices such as infusion pumps or patientvital sign monitoring equipment. One example of such a patient specificasset is the MEDLEY™ APM infusion controller module and relatedequipment manufactured by ALARIS MEDICAL SYSTEMS, INC.

It should be apparent from the above description that this embodiment ofthe present invention does not require a physical medical transactioncarrier, as described with reference to FIG. 1. In this embodiment, themedical transaction carrier takes the form of a formatted electronicmessage that contains all of the information previously described withreference to physical medical transaction carrier. Each electronicmedical transaction carrier is identified with a unique identifier thatallows the information systems of the care facility and the processorassociated with the patient specific asset 580 to communicate medicaltransaction information form the care facility's information systems tothe patient specific asset, and to validate that a medical care orderhas been delivered to a patient. This embodiment provides for the closedsystem described in reference to a physical MTC, ensuring that eachmedical care order is delivered to the right patient at the right time,and that a record of that delivery is properly communicated to andreceived by the care facility's information systems. No medicaltransaction information is cleared from the memory of the patientspecific asset 580, or marked as cleared in the facility's informationsystems, until the record of delivery of that care is validated inaccordance with the present invention.

Additionally, where a system such as ALARIS MEDICAL SYSTEMS, INC.'sMEDLEY™ Patient Care Management System is used, a physician may enter anorder using manual entry means, such as a key pad, associated with theAPM. Because the APM is in communication with the various facilityinformation systems, entry of the physician's identification may beconsidered equivalent to an electronic signature, and take the place ofa written order.

The system and method of the present invention may also be enhanced byincluding technology that allows for real-time validation of the currentpatient utilizing a method to read or detect a patient identifier suchas a wristband. For example, each patient may be identified by awristband that includes certain specified information such as name, age,allergy history and the like that are encoded into a bar code. In oneembodiment of the present invention, a bar code reader could be used toread the patient's bar codes at the same time that the MTC istransmitting its information to the PSA, thus ensuring that the rightpatient is receiving the right medication. Alternatively, the patientwristband could be replaced by a device that includes atransmitter/receiver or a passive device that could be activated using asuitable sensor to receive die above-described information from thepatient's identification device.

Additionally, the system of the present invention may be enhanced byincluding technology that allows for real-time validation of eachmedication delivered to a patient. Such a system could includetechnology for reading a bar code applied to the medication, or couldemploy optical recognition, some form of active detection using atransmitter/receiver or smart chip or computer either embedded in thelabel of the medication or located on the medication container or othermethods of positively identifying the medication. In this manner, thesystem further validates that each medication delivered to patient isidentical to the medication that is indicated in the informationcontained within the MTC.

It should be apparent to those skilled in the art that the MTC may storeand transport a wide variety of information useful to the care-giversand care-giving facilities for providing healthcare to patients. Forexample, the MTC may include a patient's unique ID, a nurse's unique ID,specific medication prescribed, and identification of the specific PSAassigned to a specific patient, the time of medication delivery, acurrent unique transaction ID identifying the current transaction ofinformation between the MTC and the PSA, or the originator of theinformation such as the hospital information system or the pharmacyinformation system. Additionally, the MTC may also include past validtransactions for a particular PSA that are not yet validated by the PSA,and may also include past validated transactions for the PSA that havealready been validated by the PSA. Moreover, the MTC, if it includesenough memory, may also be programmed to accept extra pharmacypreparation information as well as extra hospital maintenance or updateinformation. Additionally, other information may be transmitted to andfrom the MTC as needed by the hospital administration, such as vitalsigns history and trend information.

The system concept will be understood to be the unique combination ofall the previous elements into a seamless automatic methodology thatrequires no extra labor from the care-giver other than carrying theMTC's back and forth to the bedside as part of the care-giver's normalrounds. The system concept is enabled by the use of specific PC-basedsoftware with open database connectivity, MTC reader hardware at thepoint of medication preparation, and MTC reader hardware associated withpatient specific assets. The system concept is effected through the useof remote transaction methodology similar to that employed in orbitalcommunication satellite technology. Utilizing this methodology, datareceipt and validation of data receipt and validated updated systemstatus is acquired. This system concept is further effected by extendingand combining the data validation concept with that used in packet-baseddata transfer, whereby specific data packets may be lost or duplicated,but the validation is still auditably correct. For example, if aparticular MTC is not returned to the nurse station in a timely manner,information is not lost to the system. The two-way validation and checkon all transactions ensures that eventually the information will make itback to the control system database when the MTC is eventually returned.In the event that a MTC is permanently lost, a time based alert couldnotify a care-giver to take appropriate action. Because of theredundancy of the system, it should be apparent that even if a specificMTC is lost or misplaced, the information contained in the PSA willeventually be returned to the control system for validation. The systemof the present invention offers the additional advantage in that patientspecific assets may be programmed such that the PSA will not perform amedication delivery regimen unless all of the safeguards and validationsare carried out without error. In this manner, the possibility of errorin delivering the wrong medication to a patient may be minimized at thebedside. Of course, in particular situations, such as where PSAs areutilized in operating room or emergency room environments, an overridemay be built into the PSA to allow emergency usage of the PSA whennecessary.

While the PSA was described in terms of an infusion pump, the PSA, asdescribed above, may also be a vital signs monitor or other clinicaldevice interacting with a patient. For example, the patient specificasset may also be a patient feeding device.

Further, while automatic programming of a clinical device using aphysical or electronic MTC is described, manual systems are alsointended to be included within the scope of the system and method of thepresent invention. For example, some patient specific assets may existwithin a facility that are capable of communicating with the controlsystem 40 (FIG. 1) or a MTC, but which may not be capable of beingprogrammed by signals received from a MTC or directly from controlsystem 40. For those clinical devices that do not accept automaticprogramming, a nurse may read the medical transaction information fromthe MTC or from the device itself, program the device, then press a“START” or “ACCEPT” or other similar key on the device to indicatecompletion of programming. The clinical device may then communicate tothe MTC information about the medical transaction it is performing forvalidation. The MTC may later commanicate this information to thecontrol system 40 for validation. Alternatively, the clinical device maycommunicate directly to the control system 40 information about themedical transaction it is performing for validation. This approach mayalso apply where a nurse takes a vital sign measurement, such as apatient's temperature. That temperature reading is input into the MTCeither immediately or eventually, either directly from the thermometerin the form of a digital data stream, or manually by the nurse, and thatmedical transaction information will eventually be communicated to thecontrol system 40. Similarly, this approach may be used were oralmedications, such as aspirin, are dispensed.

Validation data from patient specific assets may reach the controlsystem 40 via multiple MTCs. For example, different line items of apatient's order may be communicated to the patient's bedside patientspecific assets via different MTCs. The control system 40 may validatethe line items indicated as communicated to the PSA through differentMTCs but will not clear the entire medical transaction information untilit receives information concerning all of the line items. Thus, thecontrol system will not send a message to the patient specific asset toclear the multiple line items from its memory until the control system40 is satisfied that it has received information that all of the lineitems of the medical transaction have been carried out.

In the above detailed description, well-known devices, methods,procedures, and individual components have not been described in detailso as not to obscure aspects of the present invention. Those skilled inthe art will understand those devices, methods, procedures, andindividual components without further details being provided here.Moreover, while the embodiments disclosed above are described for use ina hospital environment, it will be understood that the system and methodmay be useful in other environments as well, such as outpatient clinicsand other environments where care is delivered to a patient.

While several specific embodiments of the invention have beenillustrated and described, it will be apparent that variousmodifications can be made without departing from the spirit and scope ofthe invention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

1-75. (canceled)
 76. A system for managing information relating to thedelivery of medical care to a patient, comprising: a medical transactioncarrier comprising a machine-readable label that comprises medicaltransaction information related to the patient and at least onemedication to be delivered to the patient; and a patient specific assethaving: a scanner configured to retrieve the medical transactioninformation from the label of the medical transaction carrier; a memoryfor storing information; and a processor couple to the scanner and thememory, the processor configured to compare the information stored inthe memory of the patient specific asset to the medical transactioninformation retrieved from the medical transaction carrier to validatethe retrieved information.
 77. A system for managing informationrelating to the delivery of medical care to a patient, comprising: anelectronic medical transaction carrier comprising a formatted electronicmessage comprising a unique identifier and medical transactioninformation related to the patient and at least one medication to bedelivered to the patient; a patient specific asset having: a receiverconfigured to retrieve the medical transaction information from theelectronic medical transaction carrier; a memory for storinginformation; and a processor couple to the receiver and the memory, theprocessor configured to compare the information stored in the memory ofthe patient specific asset to the medical transaction informationretrieved from the electronic medical transaction carrier to validatethe retrieved information.